KERENDIA Film-coated tablet Ref.[49668] Active ingredients: Finerenone

Posology

The recommended target dose is 20 mg finerenone once daily.

The maximum recommended dose is 20 mg finerenone once daily.

Initiation of treatment

Serum potassium and estimated glomerular filtration rate (eGFR) have to be measured to determine if finerenone treatment can be initiated and to determine the starting dose.

If serum potassium ≤4.8 mmol/L, finerenone treatment can be initiated. For monitoring of serum potassium, see below 'Continuation of treatment.'

If serum potassium >4.8 to 5.0 mmol/L, initiation of finerenone treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on patient characteristics and serum potassium levels (see section 4.4).

If serum potassium >5.0 mmol/L, finerenone treatment should not be initiated (see section 4.4). The recommended starting dose of finerenone is based on eGFR and is presented in table 1.

Table 1. Initiation of finerenone treatment and recommended dose:

Continuation of treatment

Serum potassium and eGFR have to be remeasured 4 weeks after initiation or re-start of finerenone treatment or increase in dose (see table 2 to determine continuation of finerenone treatment and dose adjustment).

Thereafter, serum potassium has to be remeasured periodically and as needed based on patient characteristics and serum potassium levels. See sections 4.4 and 4.5 for more information.

Table 2. Continuation of finerenone treatment and dose adjustment:

^* maintain 10 mg once daily, if eGFR has decreased >30% compared to the previous measurement

Missed dose

A missed dose should be taken as soon as the patient notices, but only on the same day.

The patient should not take 2 doses to make up for a missed dose.

Special populations

Elderly

No dose adjustment is necessary in elderly patients (see section 5.2).

Renal impairment

Initiation of treatment: In patients with eGFR <25 mL/min/1.73 m², finerenone treatment should not be initiated due to limited clinical data (see sections 4.4 and 5.2).

Continuation of treatment: In patients with eGFR ≥ 15 mL/min/1.73 m², finerenone treatment can be continued with dose adjustment based on serum potassium. eGFR should be measured 4 weeks after initiation to determine whether the starting dose can be increased to the recommended daily dose of 20 mg (see ‘Posology, Continuation of treatment’ and table 2).

Due to limited clinical data, finerenone treatment should be discontinued in patients who have progressed to end-stage renal disease (eGFR <15 mL/min/1.73 m²) (see section 4.4).

Hepatic impairment

Patients with:

• severe hepatic impairment: finerenone should not be initiated (see sections 4.4 and 5.2). No data are available.
• moderate hepatic impairment: no initial dose adjustment is required. Consider additional serum potassium monitoring and adapt monitoring according to patient characteristics (see sections 4.4 and 5.2).
• mild hepatic impairment: no initial dose adjustment is required.

Concomitant medication

In patients taking finerenone concomitantly with moderate or weak CYP3A4 inhibitors, potassium supplements, trimethoprim, or trimethoprim/sulfamethoxazole, additional serum potassium monitoring and adaptation of monitoring according to patient characteristics should be considered (see section 4.4). Finerenone treatment decisions should be made as directed in table 2 (‘Posology, Continuation of treatment’).

Temporary discontinuation of finerenone may be necessary, when patients have to take trimethoprim, or trimethoprim/sulfamethoxazole. See sections 4.4 and 4.5 for more information.

Body weight

No dose adjustment is necessary based on body weight (see section 5.2).

Paediatric population

The safety and efficacy of finerenone in children and adolescents aged under 18 years have not yet been established. No data are available.

Method of administration

Oral use.

Tablets may be taken with a glass of water and with or without food (see section 5.2). Tablets should not be taken with grapefruit or grapefruit juice (see section 4.5).

Crushing of tablets

For patients who are unable to swallow whole tablets, Kerendia tablets may be crushed and mixed with water or soft foods, such as apple sauce, directly before oral use (see section 5.2).

The most likely manifestation of overdose is anticipated to be hyperkalaemia. If hyperkalaemia develops, standard treatment should be initiated.

Finerenone is unlikely to be efficiently removed by haemodialysis given its fraction bound to plasma proteins of about 90%.

3 years.

This medicinal product does not require any special storage conditions.

PVC/PVDC/Aluminium transparent calendarised blisters with 14 film-coated tablets. Pack sizes of 14, 28 or 98 film-coated tablets.

PVC/PVDC/Aluminium transparent perforated unit dose blisters with 10 × 1 film-coated tablets. Pack size of 100 × 1 film-coated tablets.

White opaque HDPE bottle with white opaque polypropylene child-resistant screw cap with sealing insert. Pack size of 100 film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.